Glycated Hemoglobin Reagent Formulation for Ambient Storage
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Solution Overview
Problem
Existing reagents for detecting glycated hemoglobin require refrigerated conditions for transportation and storage, leading to high costs and limited market expansion due to stringent temperature requirements.
Innovation Solution
A kit and method utilizing a formulation of surfactants, including nonionic, anionic, and zwitterionic surfactants, to enhance the thermal stability of boronic acid affinity chromatography reagents, allowing storage and transportation at normal temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If refrigerated conditions are used for transportation and storage, then the stability and shelf life of the reagent are improved, but the transportation cost and operational complexity increase
Solution Approach 1:
The patent changes the chemical parameters of the reagent formulation by introducing a surfactant system (Tween 80 and Triton X-100) that fundamentally alters the thermal stability characteristics of the boronic acid affinity chromatography reagent, enabling it to maintain stability at higher temperatures without refrigeration
Solution Approach 2:
The patent creates a composite reagent system combining boronic acid affinity matrix, zinc ion, buffer solution, and multiple surfactants (Tween 80 and Triton X-100) that work synergistically to provide both analytical performance and thermal stability, eliminating the need for cold chain transportation
2Duration of action of stationary object
If refrigerated conditions are used for transportation and storage, then the shelf life of the reagent is extended, but the transportation cost increases
Solution Approach 1:
The patent modifies the physical-chemical parameters of the reagent environment by adding surfactants that raise the phase transition temperature and stabilize the affinity matrix, allowing the reagent to maintain its functional properties at ambient temperatures for extended periods (6 months at 2-8°C or 3 months at 25°C)
3Temperature
If real-time temperature monitoring is implemented during transportation, then the temperature control is improved, but the supervision difficulty and cost increase
Solution Approach 1:
The patent extracts the temperature control requirement from the transportation process by formulating a reagent that is inherently stable across a wide temperature range, making external temperature monitoring and control systems unnecessary
4Reliability
If cold chain transportation is used, then the reagent stability is maintained, but the market promotion and sales expansion are limited
Solution Approach 1:
The patent creates a universal reagent formulation that can be transported and stored under multiple conditions (refrigerated at 2-8°C for 6 months, or ambient at 25°C for 3 months), making it adaptable to various market scenarios including remote areas without cold chain infrastructure, thereby expanding market reach
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The formulation extends the shelf life of glycated hemoglobin test cards to 6 months at normal temperature and 18 months under refrigeration with performance biases within acceptable ranges.
Implementation Method 1
The principle of boronic acid affinity chromatography is that boronic acid active substances directionally label glycated hemoglobin in blood samples
Implementation Method 2
boronic acid active substances directionally label glycated hemoglobin in blood samples
Implementation Method 3
the combined use of different types of surfactants can significantly improve the high-temperature tolerance of the formulation, greatly reduce transportation costs
Implementation Method 4
a filtration membrane, where the filtration membrane is capable of retaining precipitated hemoglobin
Implementation Method 5
the reagent R1 includes a boronic acid conjugate, a zinc ion, and a surfactant
Data Source
Figure 1~2
AI summary
The present invention provides a kit and a test method for testing glycated hemoglobin. The kit includes a test card, a reagent R1, and a reagent R2, where the test card includes a filtration membrane, the reagent R1 includes a buffer system, a surfactant, and an active reactant, and the reagent R2 includes a buffer system and a surfactant. In the present invention, by combining different types of surfactants in a certain proportion, a reagent for determining glycated hemoglobin has good thermal stability and can be transported and preserved at normal temperature.